TB Case-Finding, Treatment and Prevention Intervention in Thailand

NCT05581212 | Completed DMC

• 2 other identifiers: IRD-1-00121SANIN207
• Study Type: interventional
• Target: 7,455
• Locations: 1 country
• Sites: 20

Brief Summary

The project aimed to test a strategy for the early detection and prevention of tuberculosis in household contacts of tuberculosis patients in order to reduce the morbidity, mortality and transmission of this disease in Thailand. This strategy will be evaluated in comparison with the current programmatic approach through a pragmatic trial with cluster randomization (cluster randomized controlled trial) which will be conducted over the next 3 years. This project is carried out in collaboration with the Tuberculosis Division of the Ministry of Public Health of Thailand, the TB/HIV Research Foundation in Thailand and the London School of Hygiene and Tropical Medicine in England.

Conditions

Tuberculosis

Keywords

Case-finding; Preventive treatment; Public Health Pack; Household contacts

Outcome Measures

Primary Outcomes (3)

• Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - overall

  Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - overall

  Month18

• Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by age group (<15, ≥15 years)

  Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by age group (\<15, ≥15 years)

  Month18

• Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by gender

  Proportion of household contacts with active tuberculosis excluded who are initiated on tuberculosis preventive treatment within 4 weeks of the index tuberculosis patient diagnosis - by gender

  Month18

Secondary Outcomes (5)

• Proportion of participants initiated on TPT who completed TPT

  Month 18

• Proportion of participants who initiate TPT for whom treatment is discontinued due to adverse events or intolerance in the Intervention phase

  Month 18

• Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - overall

  Month 18

• Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by age group (<15, ≥15 years)

  Month 18

• Proportion of HH contacts with newly diagnosed active TB initiated on curative treatment within 4 weeks of the index TB patient diagnosis - by gender

  Month 18

Study Arms (2)

Standard of Care (Control phase)

NO INTERVENTION

In the current standard of care in Thailand, at time of diagnosis and tuberculosis (TB) treatment initiation, TB patients are being advised to tell their household (HH) contacts to consult at the TB clinic for screening and provision of either curative or preventive treatment - according to the screening outcome.

Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack (Intervention phase)

EXPERIMENTAL

In the selected provinces, individuals (≥18 years) with newly detected bacteriologically confirmed pulmonary Tuberculosis (index TB case) will be sensitized on the importance of HH contact investigation for detection and prevention of TB and stigma reduction. Index TB cases will be asked to enumerate all persons living in their HH for ≥1 month at the date of TB diagnostic (contact list), and provide their name/age/sex and relationship with the index case. Screening will be offered to each HH contact, using screening invitation cards that will be provided to the index TB case, to be handed over to each HH contact (or caregiver for children \<13 years old). Urban and Village Health Volunteers (U/VHV),will visit the HH to enhance awareness of the importance of screening for TB case-finding and prevention and facilitate liaison with the hospital. If active tuberculosis has been formally excluded, they will be eligible to receive the Tuberculosis Preventive Treatment (TPT).

Other: Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack

Interventions

Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack OTHER

Combined active case-finding, treatment and prevention of TB amongst HH contacts of TB cases, associated with initiation of standard of care (SOC) treatment in active TB cases and initiation of TB preventive therapy in those contacts without active TB, based on free screening. This intervention will be compared to the standard of care available in the country.

Tuberculosis Case-Finding, Treatment and Prevention Public Health Pack (Intervention phase)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Newly bacteriologically confirmed TB case (within 1 month of diagnosis)
• Living in the same household for the last 3 months
• Reporting at least one HH contact
• Providing written informed consent for participation in the study
• All contacts living in the same HH, defined as any person who shared the same enclosed living space as the index TB case for one or more nights or for frequent or extended daytime periods for at least one month before the TB diagnosis is made.
• Providing written informed consent (signed by adult (≥18 years) contacts; or by parents/guardians for minors \< 13 years or incapacitated people; written assent for children ≥13 years and \< 18 years).

You may not qualify if:

• Index case who do not live in the catchment area of the study cluster
• Index cases diagnosed with rifampicin resistance, multidrug resistance (MDR) or extensively drug-resistant (XDR-TB)
• Index cases who are incarcerated
• \- contact currently on TPT or on TB treatment or who finished such treatment in the last 3 months.

Sponsors & Collaborators

• Ministry of Health, Thailand: collaborator
• Institut de Recherche pour le Developpement: lead
• Tuberculosis and HIV Research Foundation: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (20)

Bang Lamung H.

Bang Lamung, Thailand

Location

Nakornping H.

Chiang Mai, Thailand

Location

Chiangrai Prachanukroh H.

Chiang Rai, Thailand

Location

Chon Buri H.

Chon Buri, Thailand

Location

Kalasin H.

Kalasin, Thailand

Location

Khon Kaen H.

Khon Kaen, Thailand

Location

Lampang H.

Lampang, Thailand

Location

Samut Prakan H.

Mueang Samut Prakan, Thailand

Location

Buriram H.

Nakhon Ratchasima, Thailand

Location

Surin H.

Nakhon Ratchasima, Thailand

Location

Maharaj Nakhon Si Thammarat H.

Nakhon Si Thammarat, Thailand

Location

Phra Nakhon Si Ayutthaya H.

Phra Nakhon Si Ayutthaya, Thailand

Location

Ratchaburi H.

Ratchaburi, Thailand

Location

Samut Sakhon H.

Samut Sakhon, Thailand

Location

Si Sa Ket H.

Si Sa Ket, Thailand

Location

Hat Yai H.

Songkhla, Thailand

Location

Songkhla H.

Songkhla, Thailand

Location

Surat Thani H.

Surat Thani, Thailand

Location

Trang H.

Trang, Thailand

Location

Sunpasitthiprasong H.

Ubon Ratchathani, Thailand

Location

Related Publications (1)

• Tovar Sanchez T, Ngamvithayapong-Yanai J, Grint D, Beneteau S, Luangjna S, Ouedraogo S, Lachenal N, Bonnet M, Fielding K, Kamolwat P, Lienhardt C. Evaluation of a combined tuberculosis case-finding, treatment and prevention strategy in Thailand: protocol for a pragmatic phase IV stepped-wedge cluster-randomised trial, the CaPThai study. Trials. 2026 Feb 16;27(1):225. doi: 10.1186/s13063-026-09532-7.

  PMID: 41699679 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Christian Lienhardt

  Institut de Recherche pour le Developpement

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Stepped-Wedge Cluster Randomised Trial design

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: October 14, 2022
• Study Start: May 7, 2024
• Primary Completion: January 6, 2026
• Study Completion: January 7, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

TH (20)